FDA
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FDA Nod Makes Perrigo’s Opill the First Oral Contraceptive to Switch to OTC Use
FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.
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Devices & Diagnostics, BioPharma
FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes
Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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FDA Lifts Partial Hold on Curis Drug, Clearing Way for Phase 2 Leukemia Study
A partial clinical trial hold has been lifted from cancer drug emavusertib and Curis has selected a dose to use in Phase 2 testing. The small molecule is being developed as a potential treatment for blood cancers.
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Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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A Startup Wins the First FDA Approval of a Cell Therapy for Type 1 Diabetes
CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.
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FDA Approves BioMarin Pharma’s Gene Therapy, the First for Hemophilia A
The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.
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Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing
Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.
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UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval
The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.
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FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
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After Second FDA Rejection, Intercept Abandons NASH Drug and Restructures
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy
Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.
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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
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FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med
The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
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Bleeding Problems Prompt FDA Partial Hold on Tests of Mersana Cancer Drug
For the second time in three months, Mersana Therapeutics is dealing with an FDA clinical hold. The partial hold on tests of its experimental ovarian cancer drug follows a full hold placed on an early-stage test of a different Mersana therapy in various types of solid tumors.
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MedCity Influencers, Legal, Health Tech
New FDA Draft Guidance Signals Acceptance of Decentralized Trials (When Done Right)
he FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.